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Summary Zusammenfassung
Background: A variety of apheresis devices are now available Hintergrund: Eine Reihe von Apheresevorrichtungen für die
on the market for plateletapheresis. We compared two aphere- Thrombozytenapherese ist mittlerweile auf dem Markt verfüg-
sis instruments (Fenwal Amicus and Fresenius COM.TEC) with bar. In der vorliegenden Arbeit werden zwei Apheresevorrich-
regard to processing time, platelet (PLT) yield and efficiency, tungen (Fenwal Amicus und Fresenius COM.TEC) hinsichtlich
and white blood cell (WBC) content. Material and Methods: der Parameter Separationszeit, Thrombozytengehalt und -effi-
Donors undergoing plateletpheresis were randomly separated zienz sowie Gehalt an weißen Blutzellen (WBC) verglichen.
into two groups (either the Amicus or the COM.TEC cell separa- Material and Methoden: Spender, bei denen eine Thrombo-
tor). Results: In the pre-apheresis setting, 32 plateletpheresis zytenapherese zum Einsatz kam, wurden randomisiert auf zwei
procedures performed with each instrument revealed no signif- Gruppen verteilt (entweder Amicus- oder COM.TEC-Zellsepa-
icant differences in donors’ sex, age, weight, height and total rator. Ergebnisse: In einem Vorapherese-Setting zeigten 32
blood volume between the two groups. However, the pre- Thrombozytenapheresevorgänge, die mit jedem Instrument
apheresis PLT count was higher with the COM.TEC than with durchgeführt wurden, keine signifikanten Unterschiede hin-
the Amicus (198 × 103/μl vs. 223 × 103/μl; p = 0.035). The blood sichtlich Geschlecht, Alter, Gewicht, Größe und Gesamtblutvo-
volume processed to reach a target PLT yield of ≥3.3 × 1011 lumen des Spenders zwischen den beiden Gruppen. Allerdings
was higher in the COM.TEC compared to the Amicus (3,481 vs. war der Präapherese-Thrombozytengehalt mit dem COM.TEC
2,850 ml; p < 0.001). The median separation time was also sig- höher als mit dem Amicus (198 × 103/μl vs. 223 × 103/μl; p =
nificantly longer in the COM.TEC than in the Amicus (61 vs. 0,035). Das prozessierte Blutvolumen, das zur Erreichung des
44 min; p < 0.001). 91 and 88% of the PLT products collected Ziel-Thrombozytengehalts von ≥ 3,3 × 1011 benötigt wurde, war
with the Amicus and the COM.TEC, respectively, had a PLT beim COM.TEC höher als beim Amicus (3481 vs. 2850 ml; p <
count of ≥3.3 × 1011 (p = 0.325). All products obtained with both 0,001). Die mediane Separationszeit war beim COM.TEC signifi-
instruments had WBC counts lower than 5 ↔ 106, as required. kant höher als beim Amicus (61 vs. 44 min; p < 0,001). 99 bzw.
There was no statistical difference with regard to collection effi- 88% der Thrombozytenprodukte, die mit dem Amicus bzw. mit
ciency between the devices (55 ± 15 vs. 57 ± 15%; p = 0.477). dem COM.TEC gesammelt wurden, hatten einen Thrombozy-
However, the collection rate was significantly higher with the tengehalt von ≥3,3 × 1011 (p = 0,325). Sämtliche mit beiden Ge-
Amicus compared to the COM.TEC instrument (0.077 ± 0.012 × räten gewonnenen Produkte wiesen die vorgeschriebene WBC-
1011 vs. 0.057 ± 0.008 × 1011 PLT/min; p < 0.001). Conclusion: Anzahl von <5 × 106 auf. In Bezug auf die Sammlungseffizienz
Both instruments collected platelets efficiently. Additionally, gab es keine Unterschiede zwischen den beiden Geräten (55 ±
consistent leukoreduction was obtained with both instruments; 15 vs. 57 ± 15%; p = 0,477). Allerdings war die Sammelrate beim
however, compared with the COM.TEC instrument, the Amicus Amicus signifikant höher als beim COM.TEC (0,077 ± 0,012 ×
reached the PLT target yield more quickly. 1011 vs. 0,057 ± 0,008 × 1011 PLT/min; p < 0,001). Schlussfolge-
rung: Beide Geräte eignen sich zur effizienten Sammlung von
Thrombozyten. Zusätzlich wird mit beiden Geräten eine deutli-
che Leukoreduktion erzielt. Allerdings lässt sich mit dem Ami-
cus der Ziel-Thrombozytengehalt schneller erreichen als mit
dem COM.TEC.
Introduction Instruments
Amicus COM.TEC p
The median blood volume processed to reach a PLT yield
(n = 32) (n = 32) value
≥ 3.3 × 1011 was significantly higher with the COM.TEC com-
Male/female 29/3 30/2 0.644 pared to the Amicus (3,481 vs. 2,850 ml; p < 0.001). Addition-
Age, years; median (range) 28 (18–43) 29 (21–49) 0.146 ally, the median flow rate of the Amicus was significantly high-
Weight, kg; mean ± SD 73.9 ± 10.4 74.1 ± 7.1 0.946 er than the median flow rate of the COM.TEC (65 vs.
Height, cm; median (range) 170 (155–185) 170 (163–180) 0.839
58 ml/min; p < 0.001). Furthermore, there was a significantly
TBV, ml; mean ± SD 5,142 ± 778 5,197 ± 464 0.696
TBV = Total blood volume. higher median volume of ACD used in collections on the
COM.TEC (373 vs. 300 ml; p < 0.001). However, the mean cit-
rate load per minute was higher in the Amicus compared to
the COM.TEC (6.6 ± 0.8 vs. 6.1 ± 0.5 ml/min) (p = 0.042). The
using an unpaired t-test or the Mann Whitney U test with regard to pre-
median time needed for the procedures was also significantly
and post-apheresis peripheral blood variables, plateletpheresis opera- longer with the COM.TEC (61 vs. 44 min; p < 0.001). The
tional variables and product variables. An unpaired t-test was used for pe- plateletpheresis procedure data are shown table 3.
ripheral blood variables (e.g. pre-apheresis Hb, pre-apheresis Htc level,
post-apheresis Hb level and post-apheresis Htc level, TBV, body weight of
donor) and plateletpheresis product variables (e.g. collection rate), which
were within normal distribution. The Mann Whitney U test was used for
Plateletpheresis Product Variables
peripheral blood variables (e.g. pre-apheresis WBC count, pre-apheresis
PLT count, post-apheresis PLT count, post-apheresis WBC count and Hb The plateletpheresis product variables are summarized in
loss% and PLT loss%), plateletpheresis operational variables (e.g. blood table 4. There were no significant differences in terms of
volume processed, flow rate, product volume and separation time) and
swirling percent, PLT yield/bag, and WBC count/bag (table 4).
plateletpheresis product variables (e.g. pH, WBC count/bag and PLT
count/bag), which were not within normal distribution. Data were ana-
However, PLT yield/blood volume processed was significantly
lyzed on the SPSS software platform (SPSS 13.0, Chicago, IL, USA). The higher with the Amicus (0.42 vs. 0.33; p < 0.001). The percent-
level of significance was set at p < 0.05. age of PLT yield ≥ 3.3 × 1011/bag was 91% (29/32) and 88%
(28/32) on the Amicus and the COM.TEC instrument, respec-
tively (p = 0.325). A CE of 55 ± 15% was obtained on the Am-
Results icus and 57 ± 15% on the COM.TEC (p = 0.477). However,
the CR was statistically higher with the Amicus (0.077 ± 0.012
The general characteristics of in total 64 donors (n = 32 in the × 1011 vs. 0.057 ± 0.008 × 1011 PLT/min; p < 0.001). All products
Amicus group and n = 32 in the COM.TEC group) are given obtained with both instruments had WBC counts lower than
in table 1. The median age of the donors was 28 (range, 18–43 5 × 106, as required. Additionally, the number of products with
years) and 29 years (range, 21–49 years) for the Amicus group <1 × 106 WBC was 30 (94%) with the Amicus and 28 (87%)
and the COM.TEC group, respectively. While there were 29 with the COM.TEC (p = 0.325).
males and 3 females in the Amicus group, there were 30 males
and 2 females in the COM.TEC group. There was also no sta-
tistically significant difference between the two groups in Adverse Effects of Plateletpheresis
terms of weight, height, and TBV of the donors.
There were no high-rate adverse events that would cause early
termination of the procedure. However, citrate-related mild
Pre- and Post-Apheresis Peripheral Blood Variables toxicity occurred more commonly on the COM.TEC (6
donors) than on the Amicus (4 donors), due probably to the
Pre- and post-apheresis PB data are shown in table 2. There larger amounts of ACD-A used (300 vs. 373 ml; p < 0.001). All
were no significant differences in pre-apheresis Hb levels, Htc reactions responded rapidly to decreased flow rates and/or
levels, and WBC counts. However, the pre-apheresis PLT oral calcium supplementation.
count was significantly higher in patients on the COM.TEC
instrument compared to the Amicus (198 × 103/μl vs. 223 ×
103/μl; p = 0.035); no statistical differences in post-apheresis Discussion
PB Hb and Htc levels were noted between the instruments.
The post-apheresis PLT count was significantly lower in the Although a variety of apheresis devices are currently available
Amicus compared to the COM.TEC group (144 × 103/μl vs. on the market for plateletpheresis procedures, there are scant
164 × 103/μl; p = 0.019); there were, however, no statistically data concerning plateletpheresis with the COM.TEC machine
significant differences between the percentages of PLT and [13, 17, 18]. Additionally, there is no published data comparing
Hb loss (table 2). the COM.TEC and the Amicus instruments used for platelet-
Pre-apheresis WBC (× 103/μl); median (range) 6.95 (4.4–11.2) 7.55 (5.1–10.4) 0.07
Post-apheresis WBC (× 103/μl); median (range) 6.6 (3.9–9.7) 6.5 (4.0–10.0) 0.746
WBC loss, %; median (range) 11.5 (0–36.2) 16 (0–25) 0.05
Pre-apheresis Hb level, g/dl; mean ± SD 15.6 ± 1.4 15.4 ± 1.3 0.540
Post-apheresis Hb level, g/dl; mean ± SD 14.6 ± 1.5 14.5 ± 1.5 0.882
Hb loss ,%; median (range) 6.5 (0–9.3) 6.3 (3.3–13.6) 0.605
Pre-apheresis Htc level, % 44.5 ± 2.7 43.5 ± 3.2 0.259
Post-apheresis Htc level, % 41.4 ± 3.1 41.7 ± 4.2 0.979
Htc loss, %; median (range) 5.5 (2.2–18.4) 5.9 (0–9.9) 0.171
Pre-apheresis PLT count (× 103/μl); median (range) 198 (159–313) 223 (180–248) 0.035*
Post-apheresis PLT count (× 103/μl); median (range) 144 (105–206) 164 (109–237) 0.019*
PLT loss, %; median (range) 32 (19–40) 29 (3–39) 0.07
Blood volume processed, ml; median (range) 2,850 (2,500–3,500) 3,481 (2,742–4,139) <0.001
Flow rate, ml/min; median (range) 65 (55–75) 58 (50–65) <0.001
ACD-A volume, ml; median (range) 300 (210–341) 373 (294–407) <0.001
Separation time, min; median (range) 44 (37–58) 61 (48–72) <0.001
Product volume, ml; median (range) 285 (260–340) 300 (300–304) <0.001
pheresis. This study documents the features of the COM.TEC PLT yield of these products was 3.11 ± 0.40 × 1011. Strasser et
and compares it to the widely used Amicus instrument with al. [13] reported a processed blood volume of 2.49 ± 0.50 l and
respect to parameters such as separation time, PLT yield, CE, a mean separation time of 54 ± 13 min for a mean PLT yield of
and WBC content. In today’s world, productivity, i.e. ‘doing 2.90 ± 0.54 × 1011 PLT using the COM.TEC. Burgstaler et al.
more in less time’, is as key a feature as yield when evaluating [9] recorded median separation times of 77 min for a median
equipment. Coffe et al. [17] recorded the French experience PLT yield of 5.03 × 1011 with the Amicus. Additionally, Ben-
on plateletpheresis with the COM.TEC cell separator; the jamin et al. [10] reported average separation times of 71.5 min
blood volume processed was 4,606–5,229 l, and the mean sepa- for median yields of 4.9 × 1011 PLT using the Amicus. In this
ration time was between 87–109 min to reach a target PLT study, the median blood volume processed to reach a target
yield of 4.74 × 1011 to 5.95 × 1011 with the COM.TEC machine. PLT yield of 3.3 × 1011 was significantly higher with the
Moog et al. [18] reported an average processed blood volume COM.TEC (3,481 vs. 2,850 ml; p < 0.001). For this reason,
of 2,826 ± 409 ml in a donation time of 55 ± 11 min; the mean there was a significantly longer mean separation time with the
COM.TEC (61 vs. 44 min; p < 0.001). On the other hand, they (p = 0.477). Compared to results reported in the literature, our
do report that sex, age, weight, TBV and pre-procedure PLT COM.TEC CE results (57 ± 15%) were similar to those re-
count affect PLT yield [13, 18]. In the present study, no signifi- ported: 52–55% [13, 17, 18]. However, our Amicus results
cant differences were noted with regard to sex, age, weight, (55 ± 15%) were lower than the reported averages of 66–73%
height and TBV between the two instruments; however, the [8–11, 19–22]. On the other hand, when comparing the instru-
median pre-procedure PLT counts were significantly different ments with regard to PLT yield/blood volume processed, the
(198 × 103/l vs. 223 × 103/l; p = 0.035). This difference in the Amicus showed a significantly higher ratio compared to the
pre-apheresis PLT counts between the two groups may be due COM.TEC (0.42 vs. 0.33; p < 0.001). Moreover, while the CR
to insufficient numbers of donors per study arm as well as to was statistically higher with the Amicus (0.077 ± 0.012 vs. 0.057
performing in different subsequent time periods. Additionally, ± 0.008; p < 0.001), the CR of both machines was comparable
there was no statistically significant difference with respect to to that reported in the literature [8, 9, 20, 23].
the median PLT yield of products per component between the Efficient platelet collection with fewer procedure-related side
separators (3.39 × 1011 vs. 3.33 × 1011; p = 0.185). effects is an important consideration for donors. The most
One important advantage of plateletpheresis is that no further common procedural adverse effects are citrate related [16–18,
manipulation is required for the product to be labeled as 24]; the incidence of citrate toxicity varies from 0.11 to 16% in
‘leukoreduced’. Leukocytes must be <5 × 106 per concentrate different studies [8, 25–28]. Citrate-related reactions have
according to USA standards and <1 × 106 per concentrate ac- been observed in 0.5% of cases on the COM.TEC machine
cording to European standards [14, 15]. Coffe et al. [17] re- [17]. Additionally, Benjamin et al. [10] reported that mild cit-
ported that the residual leukocyte levels were <1 × 106 per rate-related toxicity occurred more commonly on the Amicus
concentrate (mean 0.233 ± 0.150 × 106) in more than 97% of than on the Spectra LRS separator, as a result of the larger
the components produced (confidence interval (CI) of >95%). amount of ACD used (483 vs. 389 ml; p < 0.0001). However,
Moog et al. [18] recorded mean WBC contaminations of 0.11 these adverse reactions were successfully treated by reducing
± 0.20 × 106 with the COM.TEC. Strasser et al. [13] reported the ACD infusion rate, the amount of ACD used and/or oral
that nearly all of the PLT products collected with the calcium supplementation [13, 17, 18]. In the present study,
COM.TEC, the AS.TEC204, and the COBE spectra met the since there were significant differences between the flow rates
AABB standards as well as the more stringent European of the devices, separation time and ACD consumption were
guidelines. Using the Amicus, Laurencet et al. [20] reported also found to be statistically significant (p < 0.001). Addition-
<5 × 106 WBC in 98% of the products and <1 × 106 WBC in ally, there were statistically significant differences between the
84%. Additionally, some studies have confirmed the consis- two groups in terms of the citrate load per minute (p = 0.042).
tency of leukoreduction [9–11, 21]. In the present study, all The higher ACD consumption but lower citrate load per
products obtained with both instruments had a WBC content minute of the COM.TEC procedure may be explained with
<5 × 106 (0.30 × 106 to 1.2 × 106 vs. 0.26 × 106 to 1.43 × 106; p = the low number of donors per arm. Citrate-related mild toxic-
0.805). Additionally, the number of products with <1 × 106 ity occurred more commonly on the COM.TEC (6 donors)
WBC was 30 (94%) with the Amicus and 28 (87%) with the than on the Amicus (4 donors). However, this was not clinical-
COM.TEC instrument (p = 0.325). ly significant.
Efficient PLT collection is an important issue when comparing In conclusion, both instruments perform plateletpheresis effi-
instruments; the new generation of instruments appears to be ciently. Additionally, consistent leukoreduction was obtained
more efficient [9]. In the present study, we noted a CE of 55 ± with both machines. The Amicus, however, has the advantage
15% with the Amicus and of 57 ± 15% with the COM.TEC of a lower separation time.
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